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Sr. Statistical Programmer

Remote:

Full Remote

Contract:

Full time

Experience:

Expert & Leadership (>10 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

Bachelor's in Statistics or related field, 10+ years of relevant experience, Strong experience with Phase I studies, Hands-on creation of ADPP and ADPC datasets, Familiarity with NONMEM datasets preferred.

Key responsabilities:

Provide statistical programming expertise for early phase group
Create various ADaM safety datasets and TFLs
Conduct exposure response analysis and pooling of PK parameters
Utilize strong SAS and CDISC knowledge
Understand regulatory requirements for submissions

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

Provide hands-on Statistical Programming expertise for client's early phase translation medicine group.
Responsible for creating ADaM safety datasets such as ADSL, ADLB, ADVS, ADEX, ADPC (concentration), ADPP (parameter), and POPPK (NONMEM) datasets, PK non-compartmental (NCA) tables, figures, and listings (TFLs).
Experience with Phase I studies, exposure response analysis, cross over design, and supported pooling of PK parameters required.
Strong SAS technical skills and in-depth CDISC knowledge.
Good knowledge regulatory requirements for submissions.

Requirements:

Education/Experience: Bachelor's Degree in Statistics, Computer Sciences, Bioinformatics, or related field, and 10+ or more years of relevant experience
Strong, recent experience working on Phase 1 studies specifically with PKPD data and having created ADPP and ADPC datasets
Hands-on experience creating NONMEM datasets strongly preferred but will consider candidates who have exposure/knowledge of the process and has worked in-depth with PKPD/Phase 1 studies.
Project/Study lead experience strongly preferred but not required.